NONMEM Users Network Archive

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manager/sr. manager role in MA

From: Brenda Roseberry <broseberry>
Date: Wed, 21 Oct 2020 19:30:14 +0000

Below role is with a pharma client in MA. If interested please reach out to=
 me at broseberry
more info.

The Manager/Senior Manager will be responsible for managing and executing c=
linical pharmacology functional deliverables in collaboration with internal=
 and external partners in an efficient and scientifically rigorous manner. =
This individual will be accountable for contributing to the design, executi=
on, PKPD analysis, interpretation and reporting of clinical pharmacology st=
udy results including but not limited to first-in-human, drug interaction, =
biopharmaceutics and mass balance studies in addition to pre-clinical studi=
es that support FIH studies.


Principal Responsibilities

* The incumbent will independently represent Clinical Pharmacology as a cor=
e member of clinical trial teams: Contributing to clinical trial designs, A=
uthoring functional sections of clinical study protocols, Finalizing clinic=
al study reports. Lead internal DMPK sub-teams to define DMPK strategy for =
compound development. Align development plans with sub-teams, study teams a=
nd manager;

* Manage CROs for non-clinical, TK and clinical pharmacology related studie=
s and activities by developing study timelines, objectives and budgets, ens=
uring accuracy of project progress and completion and pro-actively identify=
ing hurdles and providing solutions.

* Analyze and interpret PK/PD data generated during conduct of the clinical=
 trials while communicating results and impact of results in a timely and e=
ffective manner to clinical study teams and development sub-teams.

* Conduct Clin Pharm based assessment of in-licensing opportunities

* Complete all required organizational trainings and requirements according=
 to corporate timelines and adhere to the appropriate SOP and GxP guideline=
s



Qualifications

Work Experience

* Around 1-3 years (manager level) (4-6 sr. manager) of pertinent experienc=
e in supporting pharmacokinetics, pharmacodynamics and other clinical pharm=
acology components of clinical trials preferably within the pharmaceutical =
or biotech industry.

* Pertinent knowledge of biologics and clinical immunology is required.

* Hands on knowledge of PK/PD and statistical analyses methods used in anal=
yzing clinical data is required.

* Excellent written and oral communication skills. Executive presentation s=
kills are necessary.

* Good track record of publishing scientific research.

Major Skills (Technical & soft skills)

* Hands-on experience with pharmacokinetic/pharmacodynamic data analyses us=
ing WinNonlin, NONMEM and potentially, other data analysis software.

* Demonstrable academic excellence in clinical pharmacology, drug metabolis=
m, protein chemistry, immunology and cell biology


[cid:1.1213385771
Brenda Roseberry
   Division Manager-Scientific
   Preclinical/Clinical--PK, Pharmacology, Pharmacometrics, Biomarkers
    720-328-9526 - Office
    315-415-4353 - Mobile (preferred)
    720-475-1176 - Fax
   [cid:image002.png
-roseberry-1608166/?msgConversationId=6641167769234657280&msgOverlay=tr=
ue>



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Received on Wed Oct 21 2020 - 15:30:14 EDT

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